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Impact of Vaccine Hesitancy on Onset, Severity and Type of Self-reported Adverse Events: A French Cross-Sectional Survey

Charles Khouri (), Ayoub Larabi, Pierre Verger, Fatima Gauna, Jean-Luc Cracowski and Jeremy Ward
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Charles Khouri: Grenoble Alpes University Hospital
Ayoub Larabi: Grenoble Alpes University Hospital
Pierre Verger: VITROME (Aix Marseille Université, IRD, AP-HM, SSA)
Fatima Gauna: Observatoire régional de la santé PACA (ORS Paca), Aix-Marseille Université
Jean-Luc Cracowski: Grenoble Alpes University Hospital
Jeremy Ward: VITROME (Aix Marseille Université, IRD, AP-HM, SSA)

Drug Safety, 2022, vol. 45, issue 10, No 5, 1049-1056

Abstract: Abstract Introduction Little is known about the impact of mandatory vaccination on people who are reluctant to be vaccinated, despite the potential importance in terms of public health policy. Objective We aimed to explore the relationship between vaccine hesitancy and onset, severity and characteristics of self-reported adverse events. Methods We used a cross-sectional online survey conducted in 2021 among a representative sample of the French population aged 18 years and older (n = 1593). All reported adverse events were analyzed and categorized by trained experts in drug safety and pharmacovigilance. Multivariate binomial regressions on the onset of self-reported adverse events, vaccine hesitancy categories and predefined responders’ characteristics were performed. Results Overall, 590 (37.0%) participants reported at least one adverse event, with 121 (20.5%) considered it to be severe. Proportions of reported adverse events, ranging from 18% (in non-reluctant responders) to 65% (in very reluctant responders), and their severity, ranging from 5% (non-reluctant responders) to 41% (very reluctant responders), depended highly on attitudes toward vaccination. The adverse events profile remained similar between groups. In the multivariate regression model, beyond attitude toward vaccination, younger age and female gender were significantly associated with higher reporting of vaccine adverse events. Conclusions Our results suggest that vaccine hesitancy could be a major driver of patient-reported vaccine-related adverse events and their perceived severity. In this context, vaccinators must pay special attention to reluctant patients and inform them on the possible nocebo nature of these adverse events so as to prevent them.

Date: 2022
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DOI: 10.1007/s40264-022-01220-0

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